Two compartment syringe package

ABSTRACT

1,043,954. Injection devices. S. J. SARNOFF and J. W. BALENGER. Jan. 25,1965 [Feb. 20,1964], No. 3259/65. Heading A5R. An injection device in which the components of the injectionable material are mixed immediately prior to injection, comprises a vial containing one component, a cartridge or container containing another component and a hollow needle, the said parts being so arranged that on relative movement of the cartridge and vial the needle penetrates the vial stopper or the said parts being so arranged that on relative movement of the vial and cartridge the needle penetrates the cartridge stopper and on subsequent relative movement the needle penetrates the vial stopper. In the embodiment of Fig. 6 the device comprises vial 132 and cartridge 102 in holder 100. The cartridge 102 carried needle 118 on which is mounted sleeve 128 which is slidable in member 130 secured to vial 132. In use the cartridge 102 is moved to the right such that the needle 118 pierces the vial stopper 138. Piston 104 is urged into the cartridge 102 such that ball valve 126 is displaced and the component in cartridge 102 is expelled into vial 132. After the components are mixed in vial 132, the mixture is withdrawn into cartridge 102 by moving piston 104 to the left. The vial 132 and its associated parts are removed from the device and the mixture may then be injected into a patient from the cartridge 102, The needle may be protected by a cover which is pierced by the needle as the cartridge and vial are moved relatively to each other. The device may be constructed such that the needle may be sterilized after the device is assembled.

5. J. SARNOFF ETAL 3,336,924 TWO COMPARTMENT SYRINGE PACKAGE Aug. 22, 1967 2 Sheets-$heet 1 Filed Feb. 20, 1964 Qm mm 9m Wm m6 9W NW w Wm Wm //V VENTURE 5 f v1 M M H R w m r .5 A J.. yW

A. 22, 1967 SARNOFF ETAL 3 TWO COMPARTMENT SYRINGE PACKAGE Filed Feb. 20, 1964 2 Sheets-Sheet 2 H M f f "H O 6 Q N my 7 m0 7 5 A 5 W Mn mm 5d United States Patent Ofiice 3,336,924 Patented Aug. 22, 1967 3,336,924 TWO COMPARTMENT SYRINGE PACKAGE Stanley J. Sarnoff, 7801 Woodmont Ave, Bethesda, Md. 20014, and John W. Balenger, Rockville, Md.; said Balenger assignor to said Sarnoff Filed Feb. 20, 1964, Ser. No. 346,307 9 Claims. (Cl. 128-272) This invention relates to a syringe and in particular to a combination of a loaded syringe with a loaded vial and associated interrelated parts whereby the contents of both syringe and vial may be mixed in the vial and then the vial contents aspirated into the syringe or administration of the syringe contents to a patient.

In the prior art, in order to administer a medicant containing a powder or equivalent to a patient, it was necessary to provide a vial filled with powder, separate and distinct from a syringe, and to apply the needle of the syringe to the interior of the vial to inject the solvent for the powder into the vial, then after dissolving the powder, aspirate the dissolved powder into the syringe and then apply the needle to a patient. Obviously with such an arrangement the top of the vial penetrated by the needle might not be sterile, and the exposed needle would be exposed to non-sterile conditions. Furthermore, the vial and syringe, being separate devices, makes it cumbersome for the physician or nurse to handle the separate parts particularly under stressed conditions that may exist at the bedside of a patient.

In another form, in the prior art, the powder or equivalent and the liquid solvent are housed in two diflerent compartments in the syringe making it necessary for the syringe to be fairly large so that it may house both materials and making the syringe cumbersome in use.

It is an object of applicants invention to provide a means whereby sterile conditions for the medicament and needle of a hypodermic syringe may be obtained at least until the time of application of the needle to the patient.

Another object of the invention is to facilitate the handling of the medicament and liquid so that they readily may be admixed and then retained in the syringe even under stress conditions which may exist at the time of administration of the medicament to a patient.

Another object of the invention is to provide a syringe package such that on telescoping movement of the parts, the needle will just completely penetrate the stopper of the vial and thereby ensure complete emptying of the vial by aspirating action through the hollow needle.

Other objects will become apparent after a consideration of the following specification when taken in conjunction with the accompanying drawings in which:

FIG. 1 is a cross-sectional view of a combination syringe in accordance with the invention.

FIG. 2 is a fragmental cross-sectional view of a modification of the invention.

FIG. 3 is a cross-sectional view of a still further modification of the invention wherein a needle of the hypodermic syringe is adapted to be penetratable into the stoppers of both a vial and a cartridge.

FIG. 4- is an enlarged View, showing a modification of the structure of FIG. 3 wherein the needle causes a ball to be displaced to give access to the barrel contents.

FIG. 5 is a fragmental sectional view of yet another modification of the invention, wherein provision is made for sterilization of the needle prior to initial telescoping of a cartridge needle support and a stopper of a vial.

FIG. 6 is a cross-sectional view of another embodiment of the invention of an initial position of parts showing another form of ball valve in a stopper.

FIG. 7 is another view of the embodiment of invention shown in FIG. 6 with the parts in telescoped condition. FIG. 8 is a fragmental view, partly in section, of an embodiment of the invention involving the provision of a temporary sheath for the needle, parts being shown prior to complete telescoping.

FIG. 9 is a fragmental view showing in enlarged proportion the sheath and adjustment elements.

FIG. 10 is a fragmental view similar to FIG. 8 but with the parts completely telescoped, and

FIG. 11 is a modification of the invention showing another form of connection between a vial and its attached telescopic member.

Now referring to the drawings in greater detail, in FIG. 1 there is shown an assembly of a hypodermic injection device or syringe 10 containing a liquid 12 and a vial 14 partially filled with a medicament 16 in any of liquid, soluble power or soluble solid forms. As an example of the invention, the syringe comprises an outer cylindrical cover 18, provided with a finger engageable flange 19, telescopingly receiving the liquid container here designated as a barrel 2t), this barrel being provided with an outwardly directed flange 22 and containing the liquid medicament or solvent 12, a plunger 24 having a thumb engaged button 26 thereon and a piston 28 within the barrel, and a hollow needle 39 'afiixed for movement with the barrel and communicating with the contents thereof. The glass vial is embraced by a protective cover 32 having opposed slots or windows 34 through whu'ch the vial contents may be observed. The vial is provided with a long neck 36 accommodating a rubber stopper 33, the rubber stopper having a shoulder 40 butting against the adjacent end of the neck. The vial cover is long enough to extend beyond the outer end of the stopper and frictionally snaps over a protuberance 41 on an adjacent end of the syringe cover. If desired, the two covers may be engaged otherwise as by a bayonet joint or screw threads.

The combination syringe is supplied as shown in FIG. 1 with the needle partially embedded in the rubber stopper. In use, the fingers of an operator engage beneath the flange 19 while pressing down with. the thumb on button 26. The vial cover is held with the other hand as a matter of precaution although the frictional or other engagement of the cover 32 with the syringe cover 13 may be relied on to hold parts together during initial operation of the syringe package. Initial pressure of the thumb causes the entire assembly within the syringe cover to move to the left, is viewed in FIG. 1 since the needle now is blocked against flow of material therethrough. As a result, the needle penetrates the stopper. Further pressure on the button on the button results in expulsion of the barrel contents through the needle and into admixture with the contents of the vial. At this time the materials may mix together or be dissolved, one within the other. If necessary the assemblage may be shaken to secure the desired result. Then the contents of the vial is aspirated into the barrel by withdrawing the plunger while holding the barrel against movement, as by proper manipulation of flange 22 and button 26. The vial cover 32 may now be manually detached from the syringe cover 18, and the hypodermic syringe then beused in a normal manner. Alternatively, the covers need not be disengaged from one another and the barrel 20 with the solute therein and plunger 24 may be withdrawn from the syringe cover 18 and utilized as a hypodermic syringe, the contents of the barrel being expelled through the needle by reason of finger and thumb engagement of the flange 22 and button 26 and pressure applied between the two.

In the form of invention disclosed in FIG. 2, the use of an outer cover on the vial and syringe is avoided. Instead, the vial 42 is provided with a neck portion 44 having at least one circular bead 46 thereabout and also a flange 48, there being a plastic outer telescopic sleeve 50 snapped onto the bead and flange. A rubber stopper 52 is retained on the vial by the shoulder 54 of the sleeve bearing against the outer surface of the stopper and a flange portion 56 of the stopper engaging the flange on the vial. The syringe associated with the vial and sleeve comprises the liquid container or barrel 20, as heretofore described, with its associated plunger. The end of the barrel surrounding the hollow needle is modified, however, to provide a long cylinder 58 forming a slip joint with the sleeve. The parts may be initially assembled as shown in FIG. 2 with the needle above the stopper, or, it may be assembled (not shown) with the needle partially embedded in the stopper. When the barrel with its cylinder 58 and sleeve are telescoped together, the needle will penetrate the stopper and mixing and aspiration of the mixed vial contents of the vial into the syringe may take place, as previously described. Then the syringe may be separated from the sleeve and utilized in a normal fashion.

In the modification shown in FIG. 3 not only is there provided the telescopic connection between sleeve 50 and a cylinder 59, but a second telescopic connection is provided between a collar 60 integral with the cylinder 59 and an elongated neck 62 of a met-a1 ring 64 crimped about a neck portion 66 of the barrel 20, the ring serving to fix a rubber stopper 68 in place in the adjacent end of the barrel. The needle 70 is fixedly held within the cylindrical portion '59 by a collar 71.

In the use of the form of invention shown in FIG. 3, the parts 59 and 50 are telescoped together to cause the needle 70 to penetrate the stopper 52 of the vial 42. Likewise, the collar 60 and elongated neck 62 are telescoped to cause the needle to penetrate the stopper 68. If desired a ball valve 73 in a channel may be provided as is shown in FIG. 4 and as is more clearly set forth in the patent to Sarnoff 3,115,136, Dec. 24, 1963. Mixing and aspiration may then be effected, as heretofore. Separation of cylinder 59 and sleeve 50 permits the normal use of the syringe.

In the modification of FIG. 5, means is provided for sterilization of the needle during the initial assembly of parts. For this purpose the sleeve 72, corresponding to sleeve 50, is provided with opposed slots 74 extending partially along the length of the sleeve from its free end. The needle end of the barrel 20 has crimped thereabout a stepped cylinder 76, the stepped cylinder rigidly supporting the needle 78 and providing two ring shoulders 80 and 82 forming stops. These stops permit distinct telescopic movements of the associated elements to be obtained. In the initial assembly of parts, the elements are located as shown in FIG. 5. The lower end of the stepped cylinder is above the 'bight of the slot 74, allowing for free movement of gases into and out of the slots. The' sleeve 72 and associated vial and barrel 20 with its stepped cylinder 76 and needle assembled as shown may be placed in a sterilizing atmosphere, and while subjected to such ambient condition may be telescoped until shoulder 80 abuts the end of sleeve 72. This displacement is sufiicient to seal off the openings afforded by slots 74. The needle may be of a length to partially penetrate the stopper 52 or not, as desired. Preferably, partial penetration is desirable. The package thus partially telescoped may then be placed at the disposal of the nurse or physician.

In use of the form of invention disclosed in FIG. 5, the parts are further telescoped to bring shoulder 82 against the free end of sleeve 72, sleeve 72 being of plastic material and of a nature to permit slight expansion thereof without cracking when the parts are telescoped. In the act of telescoping these parts, the needle will wholly penetrate the stopper 52 whereupon the syringe combination may be manipulated as heretofore to secure mixing and administration of the contents of the syringe to a patient.

The form of invention illustrated in FIGS. 6 and 7 discloses a preferred form of the invention. Referring to FIG. 6, there is disclosed a holder 100, which may be of the form disclosed in the patent to Sarnoff, No. 2,956,-

4 563, granted Oct. 18, 1960. In general, this form of holder provides a means for nesting therewithin a liquid con-- tainer, here designated as a transparent cartridge 102, the cartridge including a self contained piston 104, the holder being bifurcated inwardly from its right hand end, as viewed in FIG. 6 and provided with a ring 106 to ride along the holder to hold the bifurcations together and the cartridge in place when the cartridge is within the holder and the ring is to the right thereof. The holder is also provided with a plunger 108 which, after insertion of the cartridge into the holder, may be screw threaded into the piston. The plunger has integral therewith a button 110 and the holder has integrally formed therewith laterally extending finger pieces 112. In the contracted condition of the bifurcations, seats 114 of the holder, at the right hand end of the cartridge, and a circular shoulder 116 at the left hand end of the cartridge prevent longitudinal movement of the cartridge in the holder. The cartridge fixedly mounts the hollow needle 118 which communicates with the interior of the cartridge. For the purpose of holding the needle in place, a metallic ring 120 is crimped about a flanged neck of the cartridge, the neck being indicated at 122. The metallic ring has integral therewith a cylindrical sleeve 124 surrounding and affixed to the needle. Held between the flange of the neck 122 and the ring 120 is the stopper 125 for the cartridge, the stopper having a ball 126 in a passage 127 therein expelled into the hollow of the ring upon initial pressure being applied to the fluid in the cartridge by displacement of its piston.

Fitted over the sleeve 124 is an exteriorly shouldered inner cylindrical telescopic member 128, the shoulder thereof being indicated at 129. The fit between the sleeve and member is preferably of a frictional character so that they may not fall apart. The needle 118 extends beyond the free end of the member 128. The member 128 telescopes snugly within an outer telescopic member 130, the same being snap fitted about the neck of a vial 132 by means of a flange 134 and a ring bead 136 on the vial, as in previous embodiments. The vial, as in previous cases, is provided with medicament and a stopper 138 and, in the initial position of parts, the needle may partially penetrate the stopper, as shown.

In use of the form of invention disclosed in FIGS. 6 and 7, the operator is supplied with the assembly as shown in FIG. 6. Upon applying opposing thrusts to the two parts of the telescopic connection afforded by telescoping members 128 and 130 the needle 118, as shown in FIG. 7, penetrates the stopper 138, the longitudinal displacement of needle and stopper relative to one another being limited by engagement of shoulder 129 with the free end of telescopic member 130. The plunger 108 may now be operated to force the liquid in the cartridge 102 into the vial 132 which had been previously partially filled with a medication. After admixture of what is now contained in vial 132, or solution thereof, the material may be aspirated into the cartridge by withdrawal action of the plunger. The ball is prevented from occluding the passage in the stopper 125 by radial ribs on the face of the stopper, not shown. The telescopic member 128 may now be pulled off from the sleeve 124 and the hypodermic syringe utilized in the usual manner. The spent vial and attached parts may be discarded.

FIGS. 8, 9 and 10 show modifications over the forms of invention disclosed in FIGS. 6 and 7. Principally, the difference resides in the use of a needle end covering 140, preferably of polyethylene, said covering embracing the needle end and being integrally connected with the end of the inner telescopic member 128 by a very thin frangible web 142. It will be noted that there is an annular space 144 about the needle between the needle and the inner surface of the inner telescopic member, this space extending a long way toward the left, as viewed in FIGS. 8 to 10, from the right hand end of the member 128. In this form of the invention the needle and covering lie in the gap between the end of member 128 and the stopper. 146. The outside diameter of the covering 140 is less than the inside diameter of the telescopic member 128.

In use of the structure shown in FIGS. 8 to 10, when the telescopic members 128 and 130 are moved toward each other, the covering 140 strikes the top of stopper 146 and the web 142 fractures. Continued telescoping action causes the covering to be thrust into the space 144 between the needle and member 128, as seen in FIG. 10, while the needle penetrates the cover and the adjacent stopper 146.

To further facilitate separation of member 128 from the needle, the member 128 may be provided with a groove 148 and the companion member 130, which is of polyethylene or the like, may be provided with an inturned flange 150 to snap into the groove and hold the telescopic members 128 and ISO-together so that member 128 may be freed from the needle by a pull exerted on vial 132 while the needle is held immobile. It is obvious that this provision may be adopted as well in the form of invention disclosed in FIGS. 6 and 7.

In FIG. 11 there is shown a modification of the connection between the outer telescopic member and the vial. In this instance the vial, indicated as 156 has an outwardly turned flange 158 on its neck and a rubber diaphragm 160 positioned on the flange. The diaphragm may be ribbed circularly as indicated at 162, 164 and an aluminum ring 166 is crimped about the diaphragm and beneath the flange to hold the diaphragm sealed against the vial. The outer telescopic member 168 of polyethylene or like material is formed to snap over the aluminum ring and grasp the vial beneath the flange. For these purposes the sleeve is provided with the conical surface 170 and circular shoulder 172. The sleeve is further provided with a circular ridge 174 which in the assembled position of parts buries itself into the rubber diaphragm, preferably at the ribbed portion thereof to eflectively seal, at this point, the sleeve and diaphragm against admission of ambient atmosphere via the flange connection between the sleeve and vial. It is to be understood, that the space within the sleeve may be rendered sterile, when the inner telescopic member is inserted within the sleeve, by means such as is disclosed particularly in the construction of the form of invention shown in FIG. 5. The inner surface of the sleeve is provided with guiding portions here shown as a ring 176 and a rib 178 to frictionally retain and guide the inner telescopic member, and seal the space above the diaphragm.

It should be noted that by reason of the package construction and the telescopic connections of parts, the needle is guided to penetrate the center portion of the stopper in the vial and that by reason of proportion of parts, the needle penetrates thru the vial stopper until the opening in the needle is just within the vial. In this manner it does not require any groping on the part of the physician or nurse or adjustment of the needle relative to the depth of the vial to insure the complete emptying of the vial on syringe aspirating action.

Although it has been pointed out, specifically, tridge 102 or the equivalent contains a fluid and vial contains a powder, it is obvious that the may be interchanged or that in fact both the cartridge or syringe may contain liquids, as normally immiscible liquids, and which are mixed before use.

Having thus described the invention, what is claimed is:

1. A syringe package comprising a vial containing a medicament, a stopper closing ofl the vial, a member attached to said vial and extending beyond the stopper, a cartridge including a self-contained piston at one end thereof and an openable sealing means at the other end thereof, said sealing means initially sealing said other end of the cartridge, said cartridge fixedly carrying a needle, a sleeve surrounding the needle, a part on the needle frictionally separably engaged with and within the sleeve,

that car- -that the contents vial and enabling the sleeve to be removed from the needle, the needle protruding beyond the sleeve, said sleeve and member being frictionally telescopically engaged, whereby telescoping movement of parts causes the needle to penetrate completely through the stopper to enable the injection of the contents of the cartridge into the vial and, after aspiration of the vial contents into the cartridge, the sleeve and vial 'may be separated from the needle to permit ejection of the contents of the cartridge into a patient.

2. The structure of claim 1 wherein the cartridge is mounted in a holder and cooperating means are provided in the holder and in the cartridge whereby medicament in the cartridge may be transferred into the vial, and medicament in the vial may be transferred into the cartridge.

3. The structure of claim 2 provided with astopper,

a ball valve in the stopper,

a second telescopic connection between the cartridge and the sleeve,

said needle being aflixed to said sleeve,

the needle being of such length as to thrust the ball into the cartridge and communicate with the contents of said cartridge upon telescoping action of said second telescopic connection.

4. The structure of claim 1 wherein the sleeve has an interlocking means comprising a groove about the sleeve and the member has a flange portion resiliently engaged in the groove in the sleeve in the telescopic position of parts.

5. The structure of claim 1 wherein means are provided for limiting the telescopic movement so that the needle just penetrates through the stopper to enable the entire content of the vial to be easily aspirated through the needle.

6. The structure of claim 1 wherein the member is provided with means to form a seal with the vial stopper.

7. The structure of claim 1 wherein the member is provided with a rib opposed to the stopper and embedded in the stopper to provide a seal.

8. A syringe package comprising a vial containing a medicament, a stopper closing off the vial, a member attached to said vial and extending beyond the stopper, a cartridge fixedly carrying a needle, a sleeve surrounding the needle, a part on the needle frictionally engaged with and within the sleeve, the needle protruding beyond the sleeve, said sleeve and member being frictionally telescopically engaged whereby telescoping movement of parts causes the needle to penetrate completely through the stopper, the end of the needle having a cap thereabout connected to the sleeve by a thin web, the sleeve being spaced concentrically about the needle, the outside diameter of said cap being less than the inside diameter of the sleeve, said cap being freely slidable on the needle when the web is broken.

9. A syringe comprising a rigid vial, forming a first container and containing a medicament, a stopper closing wherein the cartridge is off the vial, a second container containing a medicament and a hollow needle carried thereby a communicate with its contents, means frictionally separably telescopically associating the vial and second container whereby, upon telescopic movement, the hollow needle will penetrate wholly thru the stopper, means connected with the second container to enable the contents thereof to be expelled into the vial and to aspirate the mixed contents into the second container, the means telescopically associating the vial with the second container includ ing a telescopic member attached to the vial and having a slotted end and a slip joint connection attached to the second container, said slip joint connection including two spaced shoulders, one of the shoulders being so spaced from the end of the connection that when said one shoulder is spaced from the end of the member the slotted end is unobturated and when the said one 7 8" shoulder abuts the member, the slot is obturated and 2,725,057 11/1955 Lockhart 128-418 when the second shoulder engages the member the slot 2,767,710 10/1956 Blackman 128-218 is still obturated and the needle penetrates completely 3,115,136 12/1963 Sarnoff 128-218 through the stopper, parts being so proportioned that I said needle penetrates the stopper substantially only FOREIGN PATENTS When the second shoulder engages the member. 7 0 95 France 1,063,341 8/ 1959 Germany. References Cted 776,404 6/1957 Great Britain. UNITED STATES PATENTS 2 7 727 1954 Lawshe 2 21 10 RICHARD GAUDET, Primary Examiner- 2,724,383 11/ 1955 Lockhart 128215 DALTON L. TRULUCK, Examiner. 

1. A SYRINGE PACKAGE COMPRISING A VIAL CONTAINING A MEDICAMENT, A STOPPER CLOSING OFF THE VIAL, A MEMBER ATTACHED TO SAID VIAL AND EXTENDING BEYOND THE STOPPER, A CARTRIDGE INCLUDING A SELF-CONTAINED PISTON AT ONE END THEREOF AND AN OPERABLE SEALING MEANS AT THE OTHER END THEREOF, SAID SEALING MEANS INITIALLY SEALING OTHER END OF THE CARTRIDGE, SAID CARTRIDGE FIXEDLY CARRYING A NEEDLE, A SLEEVE SURROUNDING THE NEEDLE, A PART ON THE NEEDLE FRICTIONALLY SEPARABLY ENGAGED WITH AND WITHIN THE SLEEVE, ENABLING THE SLEEVE TO BE REMOVED FROM THE NEEDLE, THE NEEDLE PROTRUDING BEYOND THE SLEEVE, SAID SLEEVE AND MEMBER BEING FRICTIONALLY TELESCOPICALLY ENGAGED, WHEREBY TELESCOPING MOVEMENT OF PARTS CAUSES THE NEEDLE TO PENETRATE COMPLETELY THROUGH THE STOPPER TO ENABLE THE INJECTION OF THE CONTENTS OF THE CARTRIDGE INTO THE VIAL AND, AFTER ASPIRATION OF THE VIAL CONTENTS INTO THE CARTRIDGE, THE SLEEVE AND VIAL MAY BE SEPARATED FROM THE NEEDLE TO PERMIT EJECTION OF THE CONTENTS OF THE CARTRIDGE INTO A PATIENT. 